Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Keio University

Status and phase

Terminated

Phase 2

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00367497

17-40

Details and patient eligibility

About

Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.

Enrollment

5 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of aggressive non-Hodgkin's lymphoma
Refractory to the first line chemotherapy or relapsed
Expression of CD20 on lymphoma cells
Measurable lesions on imaging studies

Exclusion criteria

Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
Circulating lymphoma cells equal to or more than 25,000/microliter
Hepatic dysfunction
Renal insufficiency
Cardiac dysfunction or arrhythmia
Sever infection (bacterial, viral)
CNS involvement
Other malignancies
Pregnancy or breast feeding